Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-01-05 @ 5:26 PM
Study NCT ID:
NCT01930435
Status:
COMPLETED
Last Update Posted:
2017-08-10
First Post:
2013-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Personalized Sterile Humidification Device for Mucositis in Head and Neck Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'yoms@radonc.ucsf.edu', 'phone': '415-353-7175', 'title': 'Dr. Sue Yom', 'organization': 'UCSF'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The primary endpoint was based on results from a prior MDASI validation study in a similar population. However, patients enrolled in this study reported a much higher level of symptoms than was recorded in this MDASI validation study.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Sterile Humidification Device, MyPurMist', 'description': 'Sterile Humidification Device Twice a day, 15 minutes each 12 weeks\n\nSterile Humidification Device', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change in Quality of Life as Measured by the Subscale MDASI-HN Score.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sterile Humidification Device, MyPurMist', 'description': 'Sterile Humidification Device Twice a day, 15 minutes each 12 weeks\n\nSterile Humidification Device'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '3.4', 'upperLimit': '5.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Mean value of [(MDASI-HN score at 6 weeks) - (MDASI-HN score at baseline)]', 'description': 'The MDASI-HN assesses the severity of symptoms at their worst in the last 24 hours on a 0-10 NRS, with 0 being "not present" and 10 being "as bad as you can imagine." There are 28 items in the MDASI-HN. There are 13 general inventory items, 6 general interference items, and the HN subscale adds 9 additional items assessing mucus in the mouth and throat, difficulty swallowing/chewing, choking/coughing, difficulty with voice/speech, skin pain/burning/rash, constipation, problems with tasting food, mouth/throat sores, and problems with teeth or gums. Scores for the subscales (general, interference, HN) are averaged so that a score is obtained from 0-10 for each subscale. The mean change in quality of life is calculated as the average scores at 6 weeks minus the average of the scores at baseline. Therefore a positive value represents a worsened quality of life and a negative value is an improvement in quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Achieving Compliance With Use of Personalized Sterile Humidification.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sterile Humidification Device, MyPurMist', 'description': 'Sterile Humidification Device Twice a day, 15 minutes each 12 weeks\n\nSterile Humidification Device: This is a personal humidification device. It is hand held and produces sterile warm vapor.'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'over entire 12 weeks duration', 'description': 'Compliance was pre-specified in the protocol as self-reported usage of the device at a level equal to or greater than 60% of the formal recommended usage. This cut-off at 60% represented the median of the distribution of the usage of the device among all patients. The outcome measure is the percentage of participants who reported using the device at a level equal to or greater than 60% of the total prescribed usage.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinician Graded CTCAE-rated Mucositis Score Over 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sterile Humidification Device, MyPurMist', 'description': 'Sterile Humidification Device Twice a day, 15 minutes each 12 weeks\n\nSterile Humidification Device'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'spread': '0.75', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'over 12 weeks duration', 'description': 'The maximum severity of clinician rating of mucositis observed over 12 weeks, as graded on a scale ranging from 1 (minimal mucositis) to 3 (confluent mucositis) to 5 (death) using the Common Terminology Criteria for Adverse Events v 4.0', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Feeding Tube Placement Among Patients Using Personalized Sterile Humidification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sterile Humidification Device, MyPurMist', 'description': 'Sterile Humidification Device Twice a day, 15 minutes each 12 weeks\n\nSterile Humidification Device'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'over 12 weeks duration', 'description': 'Feeding Tube Placement in Patients Who Use Personalized Sterile Humidification, as determined by placement of either nasogastric or gastrostomy tube. This was enumerated as the number of participants who had a feeding tube placed.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Hospitalization in Patients Who Use Personalized Sterile Humidification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sterile Humidification Device, MyPurMist', 'description': 'Sterile Humidification Device Twice a day, 15 minutes each 12 weeks\n\nSterile Humidification Device'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'during 12 weeks duration', 'description': 'Rate of Hospitalization in Patients Who Use Personalized Sterile Humidification, determined based on admission to hospital over active study period', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sterile Humidification Device, MyPurMist', 'description': 'Sterile Humidification Device Twice a day, 15 minutes each 12 weeks\n\nSterile Humidification Device'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Sterile Humidification Device, MyPurMist', 'description': 'Sterile Humidification Device Twice a day, 15 minutes each 12 weeks\n\nSterile Humidification Device'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.2', 'groupId': 'BG000', 'lowerLimit': '35', 'upperLimit': '76'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'humidification feasibility and efficacy'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-11', 'studyFirstSubmitDate': '2013-08-20', 'resultsFirstSubmitDate': '2015-12-01', 'studyFirstSubmitQcDate': '2013-08-23', 'lastUpdatePostDateStruct': {'date': '2017-08-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-11-15', 'studyFirstPostDateStruct': {'date': '2013-08-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change in Quality of Life as Measured by the Subscale MDASI-HN Score.', 'timeFrame': 'Mean value of [(MDASI-HN score at 6 weeks) - (MDASI-HN score at baseline)]', 'description': 'The MDASI-HN assesses the severity of symptoms at their worst in the last 24 hours on a 0-10 NRS, with 0 being "not present" and 10 being "as bad as you can imagine." There are 28 items in the MDASI-HN. There are 13 general inventory items, 6 general interference items, and the HN subscale adds 9 additional items assessing mucus in the mouth and throat, difficulty swallowing/chewing, choking/coughing, difficulty with voice/speech, skin pain/burning/rash, constipation, problems with tasting food, mouth/throat sores, and problems with teeth or gums. Scores for the subscales (general, interference, HN) are averaged so that a score is obtained from 0-10 for each subscale. The mean change in quality of life is calculated as the average scores at 6 weeks minus the average of the scores at baseline. Therefore a positive value represents a worsened quality of life and a negative value is an improvement in quality of life.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients Achieving Compliance With Use of Personalized Sterile Humidification.', 'timeFrame': 'over entire 12 weeks duration', 'description': 'Compliance was pre-specified in the protocol as self-reported usage of the device at a level equal to or greater than 60% of the formal recommended usage. This cut-off at 60% represented the median of the distribution of the usage of the device among all patients. The outcome measure is the percentage of participants who reported using the device at a level equal to or greater than 60% of the total prescribed usage.'}, {'measure': 'Clinician Graded CTCAE-rated Mucositis Score Over 12 Weeks', 'timeFrame': 'over 12 weeks duration', 'description': 'The maximum severity of clinician rating of mucositis observed over 12 weeks, as graded on a scale ranging from 1 (minimal mucositis) to 3 (confluent mucositis) to 5 (death) using the Common Terminology Criteria for Adverse Events v 4.0'}, {'measure': 'Rate of Feeding Tube Placement Among Patients Using Personalized Sterile Humidification', 'timeFrame': 'over 12 weeks duration', 'description': 'Feeding Tube Placement in Patients Who Use Personalized Sterile Humidification, as determined by placement of either nasogastric or gastrostomy tube. This was enumerated as the number of participants who had a feeding tube placed.'}, {'measure': 'Rate of Hospitalization in Patients Who Use Personalized Sterile Humidification', 'timeFrame': 'during 12 weeks duration', 'description': 'Rate of Hospitalization in Patients Who Use Personalized Sterile Humidification, determined based on admission to hospital over active study period'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Quality of Life'], 'conditions': ['Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'This is a single arm study of the use of a personalized sterile humidification device for 12 weeks for head and neck cancer patients undergoing radiation therapy to determine if the usage of this humidification system will result in a decrease in severity in head and neck related quality of life as measured by the MDASI HN subscale following radiation therapy as compared with historical experience. In addition, we are exploring correlative measures using CRP, IL-1, IL-6, and TNF-alpha level measurements as these are directly related to mucositis and presumably related to quality of life as indicated by the patient.', 'detailedDescription': 'The patients complete MDASI at baseline, 6 weeks, and 12 weeks. The MDASI is a validated instrument that measures symptom burden and we measure a subscale (HN) as our primary endpoint. The patients are asked to use a personal humidifier daily and complete a weekly diary showing compliance with the humidifier use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Receiving a dose of radiation therapy greater than or equal to 6000 cGy to one third of the oral cavity.\n* Receiving definitive or post-operative adjuvant radiotherapy.\n* Receiving radiotherapy or chemoradiation.\n* Of age greater than 18 years.\n* Life expectancy greater than 6 months.\n* Able to provide informed consent.\n* Participation of patients on other clinical trial protocols permitted, if not prohibited by trial guidelines.\n\nExclusion Criteria:\n\n* Undergoing induction or neoadjuvant chemotherapy prior to radiotherapy.\n* Treatment with amifostine or palifermin (keratinocyte growth factor) during radiotherapy.\n* High risk for poor compliance with radiotherapy, humidification, or follow-up as assessed by the investigator.'}, 'identificationModule': {'nctId': 'NCT01930435', 'briefTitle': 'Study of Personalized Sterile Humidification Device for Mucositis in Head and Neck Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'A Phase II Study Monitoring Quality of Life and Correlative Biomarkers of Mucositis in Head and Neck Cancer Patients Undergoing Radiation Therapy Utilizing a Personalized Sterile Humidification Device', 'orgStudyIdInfo': {'id': 'CC# 13202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sterile Humidification Device, MyPurMist', 'description': 'Sterile Humidification Device Twice a day, 15 minutes each 12 weeks', 'interventionNames': ['Device: Sterile Humidification Device']}], 'interventions': [{'name': 'Sterile Humidification Device', 'type': 'DEVICE', 'otherNames': ['MyPurMist'], 'description': 'This is a personal humidification device. It is hand held and produces sterile warm vapor.', 'armGroupLabels': ['Sterile Humidification Device, MyPurMist']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Helen Diller Family Comprehensive Center, UCSF', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Sue Yom, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'sharing on request to principal investigator, case by case basis'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}